BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVELATION 8,2-2-2,135

    MDR report key: 260147 · Received January 20, 2000

    Report

    Report Number
    2951009-2000-00002
    Event Type
    Other
    Date Received
    January 20, 2000
    Date of Event
    July 15, 1999
    Report Date
    January 18, 2000
    Manufacturer
    CARDIMA, INC.
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIANS WERE CONDUCTING THEIR OWN, EHTICS COMMITTEE APPROVED, STUDY OF BIVENTRICULAR PACING WITH COMPANY DEVICE VIA THE CORONARY VEINS. DEVICE WAS APPARENTLY LEFT IN THE HEART FOR A PERIOD OF 48 HOURS DURING THE STUDY. THEY REPORTED "...UPON RETRIEVAL OF THE CATHETER, THE WIRE TIP BROKE OFF AND REMAINED IN DISTAL POSTERIOR CARDIAC VEIN. CHEST X-RAY CONFIRMED THAT THERE WAS NO MIGRATION, AND FACILITY HAS OBSERVED NO SEQUELAE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVELATION 8,2-2-2,135 MAPPING CATHETER DRF CARDIMA, INC. * P0955

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other